BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 5

    MDR report key: 8069020 · Received November 14, 2018

    Report

    Report Number
    3005180920-2018-00893
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820861
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 NOVEMBER 2018. LOT 171119: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2017. EXPIRATION DATE: 2022-06-13 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 4/14 REFERENCE 02.07.0414APPS. LOT 135907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 MARCH 2014 . EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY PATELLA RESURFACING SIZE 2 REFERENCE 02.07.0034RP. LOT 176700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 MARCH 2018. EXPIRATION DATE: 2023-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO INFECTION 3 MONTHS AFTER THE PRIMARY. THE CURRENT PATHOGEN IS UNKNOWN. ALL HARDWARE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910614 GMK-PRIMARY FEMUR PS CEMENTED SIZE 5 FEMUR CEMENTED JWH MEDACTA INTERNATIONAL SA 171119 07630030820861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention